Printed on: Wed Feb 08 2023, 11:46:41 PM(EST) Status: Currently Official on 09-Feb-2023 DocId: GUID-9A018C96-C082-47EB-AF74-F276C1A094F5_4_en-US

Printed by: Dang Van Vu Official Date: Official as of 01-May-2020 Document Type: USP @2023 USPC
Do Not Distribute DOI Ref: 09cxx DOI: https://doi.org/10.31003/USPNF_M1150_04_01
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• ORGANIC IMPURITIES
Albendazole Standard stock solution: 5 mg/mL of USP Albendazole RS
in glacial acetic acid
Standard solution: 0.05 mg/mL of USP Albendazole RS in
glacial acetic acid from Standard stock solution
Sample solution: 10 mg/mL in glacial acetic acid
Chromatographic system
C12H15N3O2S 265.33 (See Chromatography á621ñ, Thin-Layer Chromatography.)
Carbamic acid, [5-(propylthio)-1H-benzimidazol-2-yl]-, Mode: TLC
methyl ester; Adsorbant: 0.25-mm layer of silica gel mixture
Methyl 5-(propylthio)-2-benzimidazolecarbamate Application volume: 10 µL
CAS RN®: 54965-21-8; UNII: F4216019LN. Developing solvent system: Chloroform, ether, and
DEFINITION glacial acetic acid (60:10:10)
Albendazole contains NLT 98.0% and NMT 102.0% of Analysis: Proceed as directed for Chromatography á621ñ,
albendazole (C12H15N3O2S), calculated on the dried basis. Thin-Layer Chromatography.
Samples: Standard stock solution, Standard solution, and
IDENTIFICATION Sample solution
Develop the chromatogram in the Developing solvent
Change to read: system until the solvent front has moved about
• A. ▲SPECTROSCOPIC IDENTIFICATION TESTS á197ñ, Infrared three-fourths of the length of the plate. Remove the plate
Spectroscopy: 197M▲ (CN 1-May-2020) from the developing chamber, mark the solvent front,
• B. The R F value of the principal spot of the Sample solution allow the solvent to evaporate from the plate, and

al
examine the plate under short-wavelength UV light.
corresponds to that of the principal spot of the Standard
Acceptance criteria: 0.5%; no spot, other than the principal
solution, as obtained in the test for Organic Impurities.
spot of the Sample solution, is larger or more intense than
ASSAY the principal spot of the Standard solution.
• PROCEDURE
SPECIFIC TESTS
Sample: 250 mg of Albendazole

in 100 mL of glacial acetic acid, warming gently if

necessary. Cool, and titrate with 0.1 N perchloric acid VS
ci
Analysis: Transfer the Sample to a suitable flask, and dissolve
• LOSS ON DRYING á731ñ
Analysis: Dry at 105° for 4 h.
Acceptance criteria: NMT 0.5%
to a potentiometric endpoint (see Titrimetry á541ñ). ADDITIONAL REQUIREMENTS
Perform a blank determination. Each mL of 0.1 N perchloric • PACKAGING AND STORAGE: Preserve in tight containers, and
ffi
acid is equivalent to 26.53 mg of C12H15N3O2S. store at controlled room temperature.
Acceptance criteria: 98.0%–102.0% on the dried basis • USP REFERENCE STANDARDS á11ñ
USP Albendazole RS
IMPURITIES
• RESIDUE ON IGNITION á281ñ: NMT 0.2%
O

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